Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000072617
Ethics application status
Approved
Date submitted
4/08/2005
Date registered
4/08/2005
Date last updated
28/09/2023
Date data sharing statement initially provided
4/08/2023
Date results information initially provided
4/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Glivec plus chemotherapy in blast-phase CML and Ph+ ALL
Scientific title
A Phase II Pilot Study of Glivec (imatinib mesylate formerly known as STI571) Combined with Induction Chemotherapy in Blast-Phase Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia, to evaluate safety and improve remission rate.
Secondary ID [1] 99 0
Australasian Leukaemia and Lymphoma Group (ALLG): ALLG CMLALL1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blast-Phase Chronic Myeloid Leukemia 145 0
Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia 146 0
Condition category
Condition code
Cancer 164 164 0 0
Leukaemia - Acute leukaemia
Cancer 165 165 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combined therapy with Glivec for Philadelphia-chromosome positive leukemias.
Intervention code [1] 113 0
Treatment: Drugs
Comparator / control treatment
Conventional chemotherapy for Philadelphia-chromosome positive leukemias.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 205 0
To determine the safety and tolerability of Glivec (STI571) at 600 mg daily in combination with induction chemotherapy in adult patients with CML in blast crisis or Ph+ ALL during the first 2 months of treatment
Timepoint [1] 205 0
During the first 2 months of treatment
Secondary outcome [1] 465 0
1. To investigate the efficacy of Glivec combined with induction chemotherapy in Ph+ acute leukaemias. This will be evaluated in terms of response rate (haematological, cytogenetic and molecular)
Timepoint [1] 465 0
At 4 weeks, leukaemia-free survival and overall survival at 3 years.
Secondary outcome [2] 466 0
2. To examine the inhibition of Bcr-Abl kinase activity in leukaemic blasts induced in-vivo by Glivec. This will be determined using Western blot analysis.
Timepoint [2] 466 0

Eligibility
Key inclusion criteria
1. Patients with a confirmed diagnosis of Ph+ CML in myeloid or lymphoid blast crisis, defined by the presence of the Philadelphia chromosome or Bcr-Abl fusion transcript and one or both of the following: i) >30% blasts in peripheral blood and/or bone marrow ii) Presence of extramedullary disease other than spleen and/or liver involvement (i.e. chloromas) OR Patients with a confirmed diagnosis of Ph+ ALL 2. Patients of childbearing potential must have a negative pregnancy test prior to the initiation of therapy. Male and female patients agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following the discontinuation of Glivec. 3. Written informed consent.
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Exposure to any other investigational agents within 30 days of commencing Glivec 2. Known sensitivity to Glivec or the phenylaminopyrimidine class of drugs 3. ECOG Performance Status Score > 2 (Appendix 1) 4. Left ventricular ejection fraction < 50% on a radionuclide cardiac scan or echocardiogram 5. Creatinine > 1.5 ´ the upper limit of normal (ULN) at the laboratory where the analysis was performed 6. Serum bilirubin > 2 ´ ULN 7. AST or ALT > 2.5 ´ ULN. In patients with suspected leukaemic involvement of the liver, AST or ALT > 5 ´ ULN. 8. Known HIV seropositivity 9. Any serious concomitant medical condition that could, in the opinion of the Investigator, compromise participation in the study 10. Pregnancy or breastfeeding 11. Dementia, intellectual impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2003
Actual
18/03/2002
Date of last participant enrolment
Anticipated
Actual
27/02/2007
Date of last data collection
Anticipated
Actual
31/12/2008
Sample size
Target
46
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 218 0
Commercial sector/Industry
Name [1] 218 0
Novartis Australia
Country [1] 218 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Country
Australia
Secondary sponsor category [1] 164 0
None
Name [1] 164 0
nil
Address [1] 164 0
Country [1] 164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1002 0
Royal Adelaide
Ethics committee address [1] 1002 0
Port Road
Adelaide SA 5000
Ethics committee country [1] 1002 0
Australia
Date submitted for ethics approval [1] 1002 0
Approval date [1] 1002 0
11/07/2002
Ethics approval number [1] 1002 0
Ethics committee name [2] 1003 0
Canberra
Ethics committee address [2] 1003 0
Yamba Dr, Garran ACT 2605
Ethics committee country [2] 1003 0
Australia
Date submitted for ethics approval [2] 1003 0
Approval date [2] 1003 0
Ethics approval number [2] 1003 0
Ethics committee name [3] 1004 0
Launceston
Ethics committee address [3] 1004 0
274-280 Charles St, Launceston TAS 7250
Ethics committee country [3] 1004 0
Australia
Date submitted for ethics approval [3] 1004 0
Approval date [3] 1004 0
Ethics approval number [3] 1004 0
Ethics committee name [4] 1005 0
Mater Brisbane
Ethics committee address [4] 1005 0
Level 3, Aubigny Place Raymond Terrace South Brisbane, Qld 4101
Ethics committee country [4] 1005 0
Australia
Date submitted for ethics approval [4] 1005 0
Approval date [4] 1005 0
Ethics approval number [4] 1005 0
Ethics committee name [5] 1006 0
Mater Private Med Centre
Ethics committee address [5] 1006 0
Level 3, Aubigny Place Raymond Terrace South Brisbane, Qld 4101
Ethics committee country [5] 1006 0
Australia
Date submitted for ethics approval [5] 1006 0
Approval date [5] 1006 0
Ethics approval number [5] 1006 0
Ethics committee name [6] 1007 0
Peter MacCallum
Ethics committee address [6] 1007 0
Peter MacCallum Cancer Centre
Locked Bag 1, A’Beckett Street
Victoria 8006
Ethics committee country [6] 1007 0
Australia
Date submitted for ethics approval [6] 1007 0
Approval date [6] 1007 0
Ethics approval number [6] 1007 0
Ethics committee name [7] 1008 0
Royal Brisbane
Ethics committee address [7] 1008 0
Royal Brisbane and Women's Hospital Cnr Butterfield St and Bowen Bridge Rd HERSTON QLD 402
Ethics committee country [7] 1008 0
Australia
Date submitted for ethics approval [7] 1008 0
Approval date [7] 1008 0
Ethics approval number [7] 1008 0
Ethics committee name [8] 1009 0
Royal Melbourne
Ethics committee address [8] 1009 0
300 Grattan Street
Parkville, Victoria 3050
Ethics committee country [8] 1009 0
Australia
Date submitted for ethics approval [8] 1009 0
Approval date [8] 1009 0
Ethics approval number [8] 1009 0
Ethics committee name [9] 1010 0
Royal North Shore
Ethics committee address [9] 1010 0
NSLHD Research Office, Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065??
Ethics committee country [9] 1010 0
Australia
Date submitted for ethics approval [9] 1010 0
Approval date [9] 1010 0
Ethics approval number [9] 1010 0
Ethics committee name [10] 1011 0
St Vincent's Melb
Ethics committee address [10] 1011 0
Research Governance Unit
St Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Ethics committee country [10] 1011 0
Australia
Date submitted for ethics approval [10] 1011 0
Approval date [10] 1011 0
Ethics approval number [10] 1011 0
Ethics committee name [11] 1012 0
Townsville
Ethics committee address [11] 1012 0
100 Angus Smith Dr, Douglas QLD 4814
Ethics committee country [11] 1012 0
Australia
Date submitted for ethics approval [11] 1012 0
Approval date [11] 1012 0
Ethics approval number [11] 1012 0
Ethics committee name [12] 1013 0
Westmead
Ethics committee address [12] 1013 0
Darcy Rd, Westmead NSW 2145
Ethics committee country [12] 1013 0
Australia
Date submitted for ethics approval [12] 1013 0
Approval date [12] 1013 0
12/03/2002
Ethics approval number [12] 1013 0

Summary
Brief summary
Primary Objective: Investigation of the safety and tolerability of Glivec in combination with induction chemotherapy for blast-phase chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia
Secondary Objective(s): (1) Investigation of the efficacy of Glivec combined with induction chemotherapy in Ph+ acute leukaemias (2) Biochemical evaluation of Abl kinase suppression by Glivec in leukaemic blasts

Patients aged 16-70 with CML in blast crisis or Ph+ ALL
All patients will receive Glivec 600 mg orally once daily, beginning 7 days prior to induction chemotherapy. Subsequent therapy will be delivered on one of three arms:
(1) CML in myeloid blast crisis : Chemotherapy will consist of induction with idarubicin and standard-dose cytarabine, followed by consolidation with 2 cycles of intermediate-dose cytarabine. Glivec will be administered without interruption in combination with the chemotherapy and then continued as a single agent until relapse or unacceptable toxicity.
(2) CML in lymphoid blast crisis and relapsed Ph+ ALL: Chemotherapy will consist of 8 courses of hyper-CVAD and Glivec will be administered as in Arm 1.
(3) De-novo Ph+ ALL: Chemotherapy will be given according to the French cooperative group ALL protocol (LALA 94). Glivec will be continued synchronously with induction, consolidation and maintenance chemotherapy, except for an interruption during cranial radiation.
Trial website
Trial related presentations / publications
Jason D Lickliter , Kerry Taylor , Jeff Szer , Andrew Grigg , Christopher Arthur , Timothy P Hughes , Simon Durrant , Robin Filshie , Ian Irving , Michael Seldon , Jennifer Ellacott , Andrew W Boyd , James D’Rozario , Kim Rooney , Kevin Lynch , and Ken Bradstock , for the Australasian Leukaemia and Lymphoma Group. An imatinib-only window followed by imatinib and chemotherapy for Philadelphia chromosomepositive
acute leukemia: long-term results of the CMLALL1 trial. Leukaemia and Lymphoma 56:630-638 (2015).
Public notes

Contacts
Principal investigator
Name 35859 0
Address 35859 0
Country 35859 0
Phone 35859 0
Fax 35859 0
Email 35859 0
Contact person for public queries
Name 9302 0
Associate Professor Kenneth Bradstock
Address 9302 0
Haematology Department
Westmead Hospital
Darcy Rd
Westmead NSW 2145
Country 9302 0
Australia
Phone 9302 0
+61 2 98457073
Fax 9302 0
+61 2 96892331
Email 9302 0
bradstok@icpmr.wsahs.nsw.gov.au
Contact person for scientific queries
Name 230 0
Associate Professor Kenneth Bradstock
Address 230 0
Haematology Department
Westmead Hospital
Darcy Rd
Westmead NSW 2145
Country 230 0
Australia
Phone 230 0
+61 2 98457073
Fax 230 0
+61 2 96892331
Email 230 0
bradstok@icpmr.wsahs.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified IPD data, for all data collected during the trial
When will data be available (start and end dates)?
Data available 3 months following publication, for an indefinite period
Available to whom?
Data are potentially available to:
• Researchers from not-for-profit organisations
• Commercial organisations
• Other
Based in:
• Any location
Further information:
All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Available for what types of analyses?
Any type of analysis
Assessed on a case-by-case basis
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health/). Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to info@allg.org.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19917Study protocol  info@allg.org.au Access can be requested via the Health Data Austra... [More Details]



Results publications and other study-related documents

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